Gage I, Schnitt S J, Nixon A J, Silver B, Recht A, Troyan S L, Eberlein T, Love S M, Gelman R, Harris J R, Connolly J L
Joint Center for Radiation Therapy, Beth Israel Hospital, Harvard, Medical School, Boston, Massachusetts 02215, USA.
Cancer. 1996 Nov 1;78(9):1921-8. doi: 10.1002/(sici)1097-0142(19961101)78:9<1921::aid-cncr12>3.0.co;2-#.
The relationship between the microscopic margins of resection and ipsilateral breast recurrence (IBR) after breast-conserving therapy for carcinomas with or without an extensive intraductal component (EIC) has not been adequately defined.
Of 1,790 women with unilateral clinical Stage I or II breast carcinoma treated with radiation therapy as part of breast-conserving therapy, 343 had invasive ductal histology evaluable for an extensive intraductal component (EIC), had inked margins that were evaluable for an review of their pathology slides, and received > or = 60 Gray to the tumor bed; these 343 women constitute the study population. The median follow-up was 109 months. All available slides were reviewed by one of the study pathologists. Final inked margins of excision were classified as negative > 1 mm (no invasive or in situ ductal carcinoma within 1 mm of the inked margin); negative-1 mm, or close carcinoma < or = 1 mm from the inked margin but not at the margin); or positive (carcinoma at the inked margin). A focally positive margin was defined as invasive or in situ ductal carcinoma at the margin in three or fewer low-power fields. The first site of recurrent disease was classified as either ipsilateral breast recurrence (IBR) or distant metastasis/regional lymph node failure.
Crude rates for the first site of recurrence were calculated first for all 340 patients evaluable at 5 years, then separately for the 272 patients with EIC-negative cancers and the 68 patients with EIC-positive cancers. The 5-year rate of IBR for all patients with negative margins was 2%; and for all patients with positive margins, the rate was 16%. Among patients with negative margins, the 5-year rate of IBR was 2% for all patients with close margins (negative < or = 1 mm) and 3% for those with negative > 1 mm margins. For patients with close margins, the rates were 2% and 0% for EIC-negative and EIC-positive tumors, respectively; the corresponding rates for patients with negative margins > 1 mm were 1% and 14%. The 5-year rate of IBR for patients with focally positive margins was 9% (9% for EIC-negative and 7% for EIC-positive patients). The 5-year crude rate of IBR for patients with greater than focally positive margins was 28% (19% for EIC-negative and 42% for EIC-positive patients).
Patients with negative margins of excision have a low rate of recurrence in the treated breast, whether the margin is > 1 mm or < or = 1 mm and whether the carcinoma is EIC-negative or EIC-positive. Among patients with positive margins, those with focally positive margins have a considerably lower risk of local recurrence than those with more than focally positive margins, and could be considered for breast-conserving therapy.
对于有或无广泛导管内成分（EIC）的乳腺癌，保乳治疗后切除标本的显微镜下切缘与同侧乳腺复发（IBR）之间的关系尚未得到充分明确。
在1790例接受放疗作为保乳治疗一部分的单侧临床I期或II期乳腺癌女性患者中，343例具有可评估广泛导管内成分（EIC）的浸润性导管组织学类型，其手术切缘经墨水标记可用于病理切片复查，且瘤床接受了≥60格雷的放疗；这343例女性构成研究人群。中位随访时间为109个月。所有可用切片均由一名研究病理学家复查。最终手术切除的墨水标记切缘分类如下：阴性＞1毫米（墨水标记切缘1毫米内无浸润性或原位导管癌）；阴性-1毫米（即切缘癌灶距墨水标记切缘≤1毫米但不在切缘处）；或阳性（癌灶位于墨水标记切缘处）。局灶阳性切缘定义为在三个或更少低倍视野下切缘处有浸润性或原位导管癌。复发疾病的首发部位分为同侧乳腺复发（IBR）或远处转移/区域淋巴结转移。
首先计算了所有340例5年可评估患者的复发首发部位的粗发病率，然后分别计算了272例EIC阴性癌患者和68例EIC阳性癌患者的复发首发部位的粗发病率。所有切缘阴性患者的IBR 5年发病率为2%；所有切缘阳性患者的发病率为16%。在切缘阴性患者中，所有切缘阴性≤1毫米（阴性-1毫米）患者的IBR 5年发病率为2%，切缘阴性＞1毫米患者的发病率为3%。对于切缘阴性≤1毫米的患者，EIC阴性和EIC阳性肿瘤的发病率分别为2%和0%；切缘阴性＞1毫米患者的相应发病率分别为1%和14%。局灶阳性切缘患者的IBR 5年发病率为9%（EIC阴性患者为9%，EIC阳性患者为7%）。切缘阳性程度超过局灶阳性的患者的IBR 5年粗发病率为28%（EIC阴性患者为19%，EIC阳性患者为42%）。
无论切缘＞1毫米还是≤1毫米，也无论癌灶是EIC阴性还是EIC阳性，手术切缘阴性的患者在接受治疗的乳腺中的复发率都很低。在切缘阳性患者中，局灶阳性切缘患者的局部复发风险明显低于切缘阳性程度超过局灶阳性的患者，可考虑接受保乳治疗。
